Keystone Nano, building on a successful partnership with Nalco and co-development programs with Johnson &Johnson, Eli Lilly, United Therapeutics, NanoTherapies, and the NCI, will develop multifunctional calcium phosphate NanoJackets for the simultaneous diagnosis and treatment of breast cancer. Despite advances in detection and treatment, breast cancer is still the second most common cancer among women with the chance of a woman developing breast cancer during her lifetime at an estimated 12% and over 40,000 women dying from breast cancer each year (ACS). The development of NanoJackets containing both Indocyanine Green, a FDA-approved near infrared fluorophore, for fluorescent imaging based diagnosis, as well as siRNA directed against a mutation in the PI3K gene, which occurs in approximately 25% of breast cancers, will result in a multifunctional nanoparticulate pharmaceutical that can simultaneously image and treat breast cancer. The objectives of this Phase I project are to demonstrate reproducible manufacturing of ICG-PI3KCA siRNA NanoJackets as well as in vitro and in vivo diagnostic and therapeutic efficacy for human breast cancer. If successful, these data will lay the groundwork for further development of targeted ICG-PI3KCA siRNA NanoJackets and provide the basis for an array of theranostic NanoJacket products for a variety of cancers.